Subject

Trial subjects, human subjects, participants and volunteers are synonyms for people who volunteer to take part in clinical studies (sometimes disparagingly referred to as guinea pigs). The clinical trials can include a variety of studies such as drug, medical, psychological and nutritional research. Test subjects are sometimes also required for testing of (medical) equipment. With the help of test subjects, the ultimate goal is to develop (better) drugs or gain more insight into how products or processes can be improved.

How can I participate in a clinical trial?

Once you register on our website, you are welcome to apply to participate in any of the studies you find interesting and for which you meet the criteria

When you register for a specific study, we will review your profile to confirm you meet the initial requirements. Please note that we cannot always include on our website all requirements that need to be met to participate in the study. You may therefore be excluded from a study based on our initial review despite meeting all the criteria listed on our website.

Once you are registered for the study or if an investigator would like you to participate, the investigator will invite you to an introductory interview. During this interview the investigator will provide details about the study and will answer your questions as best as they can. Together you will decide whether the study is appropriate for you. If the study seems to be a good fit and you are still interested in participating, the next step is to confirm your consent in writing. Then you can start participating. The requirements of the study will depend on what is outlined in the study protocol.

What is expected of me during the study?

If you participate in a study, you are expected to follow the study protocol and all instructions you receive from the doctor/investigator in relation to the protocol or your safety. The study protocol outlines how often you should visit the medical centre for an examination, how often you should take your medication and which assessments should be done in the medical centre. The protocol, and the assessments schedule in particular, are designed to protect your health. The medicine or product that is being tested has to be used according to the prescription provided by the doctor/investigator.

Will I receive an allowance?

As a healthy volunteer? You may receive an allowance for participating. How much you receive depends on the type of study and the burden involved. For instance, the allowance is higher if you are required to stay in a medical centre for a few nights or if you have to provide multiple blood samples.

As a patient? If you are considered a patient, and not a healthy volunteer and you are participating in a study, the law does not permit you to receive a fee for participating. You may be considered a patient even if you feel healthy. Volunteers with high-risk factors, such as a cardiovascular disorder or high cholesterol are examples of volunteers who are considered patients. You may receive an allowance for expenses you incur while participating.

Who determines the allowance amount?

Link2Trials does not determine the amounts of (expense) allowances paid to study participants. The allowance is determined by the investigator running the study. This can be a pharmaceutical company, a university or some other type of investigating centre.

Informed Consent Procedure

It is of utmost importance that the investigator informs you fully, both verbally and in writing, and in language you can clearly understand, of what the study entails and what will be expected of you as a participant. Once you have had sufficient time to consider participating, you will be asked to confirm in writing that you fully understand the study, including the requirements and risks. The investigator should be present when you sign the consent form and sign it immediately after you.

You can withdraw at any time from a study for which you have registered, or in which you are participating or delete your registration from Link2Trials, without any consequences. Providing your written permission is completely voluntary. You can withdraw from a study at any time, without providing reasons or your further treatment being affected in any way.

Each study has inclusion and exclusion criteria. These criteria determine whether you will be permitted to participate in a study. If you meet the criteria based on your profile, you may be a candidate to participate in a study. Link2Trials is not involved in agreements made between a volunteer and an investigator and or the investigating sponsor.

Link2Trials proposes studies for you to participate in and informs the investigator/sponsor who may be a suitable candidate. The investigator/sponsor pays Link2Trials a fee for expenses it incurs. The investigator/sponsor will contact you, arrange everything for you and decide whether you can participate in a study. Link2Trials does not interfere in this process.